Position on a reinforced EMA mandate (European Health Union)

AESGP feedback on the draft proposal for a Regulation on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices

In the context of the public consultation on the European Commission’s proposals to create a “European Health Union”, AESGP  has released and submitted its position on the proposal related to the reinforced EMA mandate.


AESGP would like to use the opportunity provided by the Commission to comment on the draft Regulation on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (2020/0321 (COD)).

As part of the healthcare continuum, self-care products can prevent illness, address minor health problems, reduce pressure on health systems, and its use was an essential part of facing the COVID-19 pandemic. Self-care entails a responsible self-assessment, self-treatment and self-monitoring, only possible by consumer and patient empowerment, by increased health literacy and by professional guidance on healthy lifestyle choices.

AESGP acknowledges that the EU must have all the tools and governance in place, including at high level, to build a stronger European Health Union, and ensure resilience and coordinated actions to face future health emergencies. The role of existing EU agencies, such as the European Medicines Agency (EMA), should be further reinforced not only with greater competences but also with sufficient allocation of resources in terms of staff and funding. In line with this Commission’s commitment for a sound and flexible regulatory system, AESGP agrees that it is crucial to pursue a better regulation agenda for a modern pharmaceutical sector, to reduce red tape and improve access and timelines, after an impact assessment that addresses the specificities of the assorted range of medicinal products and medical devices.

AESGP fully supports the general objectives of the proposal to:

  • ensure a high level of human health protection by strengthening the Union’s ability to manage and respond to public health emergencies, which have an impact on medicinal products and medical devices, and
  • contribute to ensuring the smooth functioning of the internal market for such products during public health emergencies.


Nonetheless, AESGP would like to share significant concerns on the draft proposal for consideration by the Commission and asks for:

  • an impact assessment to accompany this legislative proposal;
  • where appropriate, a revision of the draft proposal to address the concerns as described in the position.


It is paramount that a tailored approach for medicine and medical device management focusing on public health emergency preparedness is further assessed in the broader context of the Pharmaceutical Strategy for Europe so as to avoid unnecessary duplication of initiatives, to guarantee a proportional and adequate effort allocation, and to create the necessary synergies with other policies and stakeholders.

AESGP also calls EU decision makers to continue their efforts in establishing the necessary infrastructure to make the new regulatory frameworks for medical devices and in vitro diagnostics a success. Having a functioning legislative framework is a prerequisite to ensure the continued patient access to existing and new medical technologies, especially during a health crisis.

AESGP is determined to further contribute to the discussions on COVID-19 recovery and resilience to prepare and manage future health threats.


Read the full position:

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